Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: NexoBrid   
Auth. number : EU/1/12/803
Active substance : Concentrate of proteolytic enzymes enriched in bromelain
Orphan market exclusivity for "Treatment of partial deep dermal and full thickness burns" (based on designation EU/3/02/107) started on 20/12/2012
   10 years of market exclusivity
   This orphan market exclusivity will expire on 20/12/2022
ATC: Anatomical main group: D - Dermatologicals
Therapeutic subgroup: D03 - Preparations for treatment of wounds & ulcers
Pharmacological subgroup: D03B - Enzymes
Chemical subgroup: D03BA - Proteolytic enzymes
Chemical substance: D03BA03 - Bromelains
(See WHO ATC Index)
Indication: NexoBrid is indicated for removal of eschar in adults with deep partial- and full-thickness thermal burns.
Marketing Authorisation Holder: MediWound Germany GmbH
Eisenstr. 5, D-65428 Ruesselsheim, Deutschland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
20/12/2012 Centralised - Authorisation EMEA/H/C/2246 (2012)9858 of 18/12/2012
23/09/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2246/T/2 (2013)6218 of 19/09/2013
29/10/2013 Centralised - Variation EMEA/H/C/2246/IA/4/G
Updated with Decision(2014)8295 of 30/10/2014
18/06/2014 Centralised - Variation EMEA/H/C/2246/IA/15/G
Updated with Decision(2014)8295 of 30/10/2014
21/08/2014 Centralised - Variation EMEA/H/C/2246/II/9
Updated with Decision(2014)8295 of 30/10/2014
03/11/2014 Centralised - Yearly update (2014)8295 of 30/10/2014